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EC number: 812-925-4 | CAS number: 1639345-42-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 10 - June 16, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 4-[fluoro(dimethyl)silyl]butanenitrile
- EC Number:
- 812-925-4
- Cas Number:
- 1639345-42-8
- Molecular formula:
- C6H12FNSi
- IUPAC Name:
- 4-[fluoro(dimethyl)silyl]butanenitrile
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: WISTAR rats Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Weight at study initiation: step 1: 146 – 165 g; step 2: 147 – 178 g; step 3: 143 – 156 g
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw
fibre bedding
- Diet: Free access to Altromin 1324 maintenance diet for rats and mice
- Water: Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water,
municipal residue control, microbiological controls at regular intervals)
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test item was administered at a dose volume of 10 mL/kg body weight.
- Doses:
- step 1: 300 mg/kg bw
step 2: 300 mg/kg bw
step 3: 2000 mg/kg bw - No. of animals per sex per dose:
- 3 females per step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A careful clinical examination was made several times on the day of dosing (at least once during the
first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as
symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs
once daily until the end of the observation period. All abnormalities were recorded. The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Gross necropsy of survivors performed: yes
- Other examinations performed: Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also
respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and
behaviour pattern were examined. Particular attention was directed to observations of tremor,
convulsions, salivation, diarrhoea, lethargy, sleep and coma..
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Step 1: female, 300 mg/kg bw; number of animals: 3, number of deaths: 1
Step 2: female, 300 mg/kg bw, number of animals: 3, number of deaths: 0
Step 3: female: 2000 mg/kg bw; number of animals: 3, number of deaths: 3 - Clinical signs:
- The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg
bw were reduced spontaneous activity, moving the bedding, hunched posture, slow movements,
ataxia, piloerection, eyes half closed, eyes closed and salivation. The clinical signs persisted until
intercurrent death on day 2 or on day 3 of treatment.
The most relevant clinical findings in the animals treated with the test item at a dose of 300 mg/kg
bw were reduced spontaneous activity, moving the bedding, recumbency, hunched posture, wasp
waist, piloerection and eyes half closed. In the surviving animals (5 out of 6), all symptoms
recovered within the next day. - Body weight:
- Throughout the 14-day observation period, the weight gain of the surviving animals was within the
normal range of variation for this strain. - Gross pathology:
- Macroscopic findings of surviving animals:
At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.
Macroscopic findings of animals not having survived until the end of the observation period:
Necropsy revealed either mucous or blood with or without residual test item in the stomach.
Additionally, in most of the animals which had died intercurrently, either blood or a gaseous
distension were found in the intestine.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions of the present study, a single oral application of the test item 3-
Cyanopropyldimethylfluorosilane to rats at a dose of 300 mg/kg body weight was associated with
signs of toxicity and mortality.
Under the conditions of the present study, a single oral application of the test item 3-
Cyanopropyldimethylfluorosilane to rats at a dose of 2000 mg/kg body weight was associated with
signs of toxicity and mortality.
The median lethal dose of 3-Cyanopropyldimethylfluorosilane after a single oral administration to
female rats, observed over a period of 14 days is:
LD50 cut-off (rat): 500 mg/ kg bw - Executive summary:
The acute toxic class method according to OECD Guideline No. 423 was performed with the test item. It is the princicple of the acute toxic class methode that, based on a stepwise procedure with the use of a minimum number animals per step, sufficient information is obtained on the acute toxicity of the test item to enbale its classification.
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 300 mg/kg body weight. The test item was dissolved in the vehicle corn oil at a concentration of 0.03 g/mL and administered at a dose volume of 10 mL/kg. One group of three female WISTAR Crl: WI(Han) rats was treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was dissolved in the vehicle corn oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
One animal treated with the test item at a dose of 300 mg/kg and all animals treated with the test item at a dose of 2000 mg/kg were found dead on day 2 or on day 3 of treatment. All remaining animals survived until the end of the study showing signs of toxicity on the day of treatment. The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, moving the bedding, hunched posture, slow movements, ataxia, piloerection, eyes half closed, eyes closed and salivation. The clinical signs persisted until intercurrent death on day 2 or on day 3 of treatment. The most relevant clinical findings in the animals treated with the test item at a dose of 300 mg/kg bw were reduced spontaneous activity, moving the bedding, recumbency, hunched posture, wasp waist, piloerection and eyes half closed. In the surviving animals (5 out of 6), all symptoms recovered within the next day.
Throughout the 14-day observation period, the weight gain of the surviving animals was within the normal range of variation for this strain. Macroscopic findings of surviving animals: At necropsy, no treatment-related macroscopic findings were observed in any animal of any step. Macroscopic findings of animals not having survived until the end of the observation period: Necropsy revealed either mucous or blood with or without residual test item in the stomach. Additionally, in most of the animals which had died intercurrently, either blood or a gaseous distension were found in the intestine.
According to the acute toxic class method regime, no further testing was required.
Therefore, according to OECD Guideline 423, a sufficient estimation of the acute oral toxicity of the test item is provided.
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